Date (and time, if applicable and known) the data were collected. This may be the date/time a particular examination or procedure was performed.

Assessment Date/Time

Date or Date & Time

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).Injury through the spinal column is defined as any break, rupture, ligament tear, disruption, or crack through the bony vertebral elements or through the non-bony disc and ligamentous soft tissues between the vertebrae from the occipital condyles to the sacrum. Patients with cervical spondylosis and spinal stenosis may suffer a traumatic spinal cord injury without a spinal column injury.

Indicator of whether there was any disruption through the spinal column including the bony vertebral elements and their supporting ligaments, capsules, discs, and other supporting soft tissues.

Spinal column injury (-ies)

Yes;No;Unknown;

Yes;No;Unknown;

Alphanumeric

Being able to distinguish between single versus multiple levels of spinal column injury is often challenging. Critical to this distinction is the fact that a single injury may occur; i) at one vertebral level (e.g. C6 Burst Fracture); ii) at a single motion segment (e.g. a C5-6 bilateral facet dislocation) where a motion segment is defined as two adjacent vertebrae and their interconnecting discs and ligamentous structures; or iii) over two or more adjacent and contiguousmotion segments (e.g. a “teardrop” fracture of C6 where the injury spans C5-C7). Alternately, a multiple level injury consists of two or more single column injuries separated by at least one completely intact vertebra or motion segment(e.g. a C5-6 facet dislocation and a C2 hangman’s fracture).

Number assigned to the spinal column injury. The spinal column injuries are assigned numbers starting with the most cephalic spinal column injury.

Spinal column injury number

Numeric Values

1 – Most cephalic spinal column injury involving one or more adjacent vertebral levels and/or one or more adjacent and contiguous motion segments. 2 – If there are two or more discrete spinal column injuries, this is the second most cephalic spinal column injury involving one or more adjacent vertebral levels and/or one or more adjacent and contiguous motion segments separated by at least one intact vertebral level to the above or below spinal column injury. 3, 4, etc. If there are three or more discrete spinal column injuries, this is the third, fourth, etc. most cephalic spinal column injury involving one or more adjacent vertebral levels and/or one or more adjacent and contiguous motion segments separated by at least one intact vertebral level to the above or below spinal column injury. 99 - Unknown

The element may be included if relevant to the study. For additional details like permissible values, see the data dictionary associated with this CRF.The element may be included if relevant to the study. For additional details like permissible values, see the data dictionary associated with this CRF.vC00 represents C0 and is the occiput. The code vX99 should be used only if the level is completely unknown. In the case of multiple spinal injuries, a separate entry will be completed for each spinal column injury level.

For each of the level(s) of the spinal-injured vertebra(e) whether there was evidence of either a disc or a posterior ligamentous complex injury (occiput to sacrum). Posterior ligamentous complex injury is defined as the presence of acute disruption or injury to the posterior ligamentous complex through the spinal column from the occiput to the level of the sacrum. Disc Injury is defined as a traumatic disruption of the annulus of the disc through either distraction, translation, or rotation. It will also include a traumatic disc protrusion causing a spinal cord injury. Isolated traumatic disc injuries commonly occur with hyper-extension mechanisms in the cervical spine.

Disc/posterior ligamentous complex injury

Yes;No;Unknown;

Yes;No;Unknown;

Alphanumeric

Choose one - This is to be filled in for each level of injury, starting with the most cephalic injury. Acute injury to the posterior ligamentous complex should be diagnosed clinically or radiographically. Clinical evidence relies on the presence of marked local bruising and/or a palpable interspinous gap possibly with local tenderness. Radiologic diagnosis is dependent on the existence of a widened interspinous space on AP or lateral x-ray or reformatted CT of the spine, or by appropriate MRI. It may also appear as avulsion of a bone from the spinous processes or lamina. When a traumatic injury to the disc and annulus occurs in association with posterior element distraction, subluxation, or dislocation, this will be recorded as a disc and posterior ligamentous complex injury. In the case of multiple spinal column injuries, a separate entry will be filled out for each level of spinal column injury.Posterior ligamentous complex injury will be defined as the presence of acute disruption or injury to the posterior ligamentous complex through the spinal column from the occiput to the level of the sacrum. Acute injury to the posterior ligamentous complex will be diagnosed clinically or radiographically. Clinical evidence relies on the presence of marked local bruising and/or a palpable interspinous gap possibly with local tenderness. Radiologic diagnosis is dependent on the existence of a widened interspinous space on AP or lateral x-ray or reformatted CT of the spine, or by appropriate MRI. It may also appear as avulsion of a bone from the spinous processes or lamina. Disc Injury will be defined as a traumatic disruption of the annulus of the disc through either distraction, translation, or rotation. It will also include a traumatic disc protrusion causing a spinal cord injury. Isolated traumatic disc injuries commonly occur with hyperextension mechanisms in the cervical spine. When a traumatic injury to the disc and annulus occurs in association with posterior element distraction, subluxation, or dislocation, this will be recorded as a disc and posterior ligamentous complex injury. In the case of multiple spinal column injuries, a separate entry will be filled out for each level of spinal column injury.

For each of the spinal column injury level(s) whether there was any traumatic translation (occiput to sacrum). Translation is defined as sagittal and/or coronal plane mal-alignment of adjacent vertebra as seen on lateral and/or AP radiographs respectively; it consists of movement of 3.5 mm or more of one cervical vertebra on top of the adjacent vertebra or movement of 2.5 mm or more of one thoracic and lumbar vertebra on top of the adjacent vertebra1 (on available imaging).

Traumatic translation

Yes;No;Unknown;

Yes;No;Unknown;

Alphanumeric

Choose one - This is to be filled in for each level of injury, starting with the most cephalic injury. Malalignment that was caused by a degenerative process such as degenerative spondylolisthesis is not considered traumatic translation, and the value "No" should be recorded. In the case of multiple spinal injuries, a separate entry will be filled out regarding each level.Translation will be defined as sagittal and/or coronal plane malalignment of adjacent vertebra as seen on lateral and/or AP radiographs respectively; it consists of movement of 3.5 mm or more of one cervical vertebra on top of the adjacent vertebra or movement of 2.5 mm or more of one thoracic and lumbar vertebra on top of the adjacent vertebra (on available imaging). Malalignment that was caused by a degenerative process such as degenerative spondylolisthesis is not considered traumatic translation, and the value "0" (No) should be recorded. In the case of multiple spinal injuries, a separate entry will be filled out regarding each level.

Record any assistance device utilized at the time of evaluation to augment ventilation. For each device indicate if it was utilized at the time of evaluation.Respiratory insufficiency is common following spinal cord lesions. Ventilatory assistance devices include, but are not limited to: mechanical ventilators, phrenic nerve stimulators, diaphragmatic pacers, external negative pressure devices, and bi-level positive airway pressure (BiPAP). These devices do not include routine administration of oxygen, intermittent positive pressure breathing (IPPB), or continuous positive airway pressure (CPAP). Wording of this variable reflects the International Spinal Cord Injury Core Data Set for the type of ventilatory assistance used to sustain respiration at discharge after the initial rehabilitation period following the spinal lesion (DeVivo et al. 2006). As the situation may have changed since discharge from the initial inpatient period the question is asked.

Less than 24 hours per day;24 hours per day;Unknown number of hours per day;

Less than 24 hours per day;24 hours per day;Unknown number of hours per day;

Alphanumeric

Respiratory insufficiency is common following spinal cord lesions. Ventilatory assistance devices include, but are not limited to: mechanical ventilators, phrenic nerve stimulators, diaphragmatic pacers, external negative pressure devices, and bi-level positive airway pressure (BiPAP). These devices do not include routine administration of oxygen, intermittent positive pressure breathing (IPPB), or continuous positive airway pressure (CPAP). Wording of this variable reflects the International Spinal Cord Injury Core Data Set for the type of ventilatory assistance used to sustain respiration at discharge after the initial rehabilitation period following the spinal lesion (DeVivo et al. 2006). As the situation may have changed since discharge from the initial inpatient period the question is asked.

For each pulmonary complication or condition indicate if occurred within the last year.Pneumonia is one of the leading causes of mortality in individuals with spinal cord lesions (Hartkopp et al. 1997; DeVivo et al. 1999; Lidal et al. 2007), therefore it is important to record this information in detail and whenever possible. Other respiratory complications and conditions may develop after sustaining a spinal cord lesion, including atelectasis (lung collapse), and other disorders with high disease prevalence in the general population (i.e. asthma, COPD). Sleep apnea, either obstructive or central in etiology, is a common yet frequently unrecognized condition among individuals with spinal cord lesions (Leduc et al. 2007; Berlowitz et al. 2005). Sleep apnea may adversely affect sleep quality and daytime functioning, and studies in the general population suggest that obstructive sleep apnea is a risk factor for hypertension, stroke, and myocardial infarction.

Pulmonary complication or condition after spinal cord lesion within last year type

Multiple Pre-Defined Values Selected

C18783

Pulmonary condition after spinal cord lesion last year other text

PulmnCndAftrSpnlCrdLsnLstYrOTH

The free-text field related to 'Pulmonary condition after spinal cord lesion last year type' specifying other text. Type of pulmonary complication or condition that may have occurred after the spinal cord lesion (within the last year)

Other, specify

Alphanumeric

For each pulmonary complication or condition indicate if occurred within the last year.

For each event related to cardiovascular function after spinal cord lesion record whether it was experienced by the participant.These time-limited cardiovascular events with long-term sequelae should have their dates documented to be able to compute the time since injury and to identify the data collected in relation to various time points. If more than one episode has occured the last one has to be documented.

The free-text field related to 'Cardiovascular event after spinal cord lesion type' specifying other text. Events related to cardiovascular functions that may have occurred at any time after the spinal cord lesion.

For each type of cardiovascular function after spinal cord lesion record whether it was experienced by the participant within the last three months.Cardiac conditions: Subjective symptoms related to the heart that occur post-spinal cord lesion should be documented (e.g. abnormal heart rates/rhythm, angina, palpitation etc.). Orthostatic hypotension: Symptomatic or asymptomatic decrease in blood pressure usually exceeding 20 mmHg systolic or 10 mmHg diastolic on moving from the supine to an upright position. Dependent oedema: A clinically detectable increase in extracellular fluid volume localized in a dependent area, such as a limb, characterized by swelling or pitting. Hypertension: (arterial blood pressure >140/90 mmHg). The diagnosis of hypertension in individual with SCI should be considered after careful monitoring and documentation of the level of arterial blood pressure and exclusion of possible elevation of BP due to episodes of AD. Autonomic dysreflexia: A constellation of signs and/or symptoms in SCI above T5-6 spinal cord segments in response to noxious or non-noxious stimuli below the level of injury defined by an increase in systolic blood pressure (> 20mm Hg above baseline), and which may include one of the following symptoms: headache, flushing and sweating above the level of the lesion, vasoconstriction below the level of the lesion, and dysrhythmia. This syndrome may or may not be symptomatic and may occur at any time following SCI.

Cardiovascular function within the last three months after spinal cord lesion type

Multiple Pre-Defined Values Selected

C18795

Cardiovascular function after last three month other text

CardioFuncAfterLast3MnthOTH

The free-text field related to 'Cardiovascular function after last three month type' specifying other text. Types of cardiovascular function that may have occurred after the spinal cord lesion (within three months).

Indicator of whether the participant is aware that he/she needs to empty his/her bladder.

Awareness of the need to empty the bladder

No;Yes;Not applicable;Not known;

No;Yes;Not applicable;Not known;

Alphanumeric

Choose one. Awareness of the need to empty the bladder indicates any kind of bladder sensation as defined by International Continence Society (Abrams et al. 2002), i.e. normal (the individual is aware of bladder filling and increasing sensation up to a strong desire to void), increased (the individual feels an early and persistent desire to void), reduced (the individual is aware of bladder filling but does not feel a definite desire to void) or non-specific bladder sensation (the individual reports no specific bladder sensation, but may perceive bladder filling as abdominal fullness, vegetative symptoms like sweating or spasticity). No awareness of the need to empty the bladder should be noted as "no". Absent bladder sensation according to the definition of bladder sensation by the International Continence Society (the individual reports no sensation of bladder filling or desire to void) (Abrams et al. 2002) is not exactly the same as filling sensation and desire to void can be absent while temperature sensation or electrosensation can be present. "Not applicable" is to be used when the individual with spinal cord lesion has for example an unclamped indwelling catheter or non-continent urinary diversion.

Comprises various manoeuvres aimed at increasing intravesical pressure in order to facilitate bladder emptying. The most commonly used manoeuvres are abdominal straining, Valsalva’s manoeuvre and Credé manoeuvre (Abrams et al. 2002).;Comprises various manoeuvres performed by the individual with spinal cord lesion or an attendant in order to elicit reflex detrusor contraction by exteroceptive stimuli. The most commonly used manoeuvres are suprapubic tapping, thigh scratching and anal/rectal manipulation (Abrams et al. 2002).;Includes Credé manoeuvre.;An indwelling catheter remains in the bladder, urinary reservoir or urinary conduit for a period of time longer than one emptying (Abrams et al. 2002).;Is defined as drainage or aspiration of the bladder or urinary reservoir/continent urinary diversion with subsequent removal of the catheter.;Is performed by an attendant (e.g. family member or personal aid);Is performed by the individual with spinal cord lesion himself/herself;Implies that there is no voluntary triggering of the voiding, but the individual with spinal cord lesion just let the urine run by itself when the reflex detrusor contraction occur by itself.;Non-continent urinary diversion/ostomy;Voluntary initiation of micturition without reflex stimulation or compression of the bladder. This does not presume entirely normal function (Levi and Ertzgaard 1998).;Other method, specify;Sacral anterior root stimulation;Includes abdominal straining, Valsalva’s manoeuvre.;Suprapubic;indicates, that the urine is drained through a catheter via the abdominal wall.;Indicates, that the urine is drained through a catheter placed in the urethra.;Unknown;Indicates that the bladder reflex is triggered by the spinal cord lesioned individual him/herself or by the attendant.;

Alphanumeric

For each method of bladder emptying, indicate whether this is a main or a supplementary method. Two main and more supplementary methods may be indicated (adopted from Levi and Ertzgaard 1998).Normal voiding: Voluntary initiation of micturition without reflex stimulation or compression of the bladder. This does not presume entirely normal function (Levi and Ertzgaard 1998). Bladder reflex triggering comprises various manoeuvres performed by the individual with spinal cord lesion or an attendant in order to elicit reflex detrusor contraction by exteroceptive stimuli. The most commonly used manoeuvres are suprapubic tapping, thigh scratching and anal/rectal manipulation (Abrams et al. 2002). Voluntary bladder reflex triggering indicates that the bladder reflex is triggered by the spinal cord lesioned individual him/herself or by the attendant. Involuntary bladder reflex triggering imply that there is no voluntary triggering of the voiding, but the individual with spinal cord lesion just let the urine run by itself when the reflex detrusor contraction occur by itself. Bladder expressioncomprises various manoeuvres aimed at increasing intravesical pressure in order to facilitate bladder emptying. The most commonly used manoeuvres are abdominal straining, Valsalva’s manoeuvre and Credé manoeuvre (Abrams et al. 2002). Straining includes abdominal straining, Valsalva’s manoeuvre. External compression includes Credé manoeuvre.Catheterisation is a technique for bladder emptying employing a catheter to drain the bladder or a urinary reservoir (Abrams et al. 2002). Intermittent catheterisation is defined as drainage or aspiration of the bladder or urinary reservoir / continent urinary diversion with subsequent removal of the catheter. The following types of intermittent catheterisationare defined by the International Continence Society (Abrams et al. 2002): Intermittent self-catheterisation is performed by the individual with spinal cord lesion himself/herself Intermittent catheterisation can also be performed by an attendant (e.g. Family member or personal aid) Indwelling catheterisation:an indwelling catheter remains in the bladder, urinary reservoir or urinary conduit for a period of time longer than one emptying (Abrams et al. 2002). Transurethral indwelling catheterisationindicates that the urine is drained trough a catheter placed in the urethra. Suprapubic indwelling catheterisation indicates that the urine is drained trough a catheter via the abdominal wall. Sacral Anterior Root Stimulator (SARS): Emptying the bladder by electrical stimulation of the anterior sacral nerve roots via implanted electrodes. Non-continent urinary diversion/ostomy: This includes ureteroileocutaneostomy (Bricker conduit), ileovesicostomy, vesicostomy. If any other method is used for bladder emptying it is recommended to be written in a text-field, from which it will be possible to retrieve more detailed data when necessary. Because other methods of bladder emptying are generally rare, it is not practical to give an inclusive list of bladder emptying methods. Use of diapers etc. because of incontinence is not to be reported here,but under “Collecting appliances for urinary incontinence”.

Comprises various manoeuvres aimed at increasing intravesical pressure in order to facilitate bladder emptying. The most commonly used manoeuvres are abdominal straining, Valsalva’s manoeuvre and Credé manoeuvre (Abrams et al. 2002).;Comprises various manoeuvres performed by the individual with spinal cord lesion or an attendant in order to elicit reflex detrusor contraction by exteroceptive stimuli. The most commonly used manoeuvres are suprapubic tapping, thigh scratching and anal/rectal manipulation (Abrams et al. 2002).;Includes Credé manoeuvre.;An indwelling catheter remains in the bladder, urinary reservoir or urinary conduit for a period of time longer than one emptying (Abrams et al. 2002).;Is defined as drainage or aspiration of the bladder or urinary reservoir/continent urinary diversion with subsequent removal of the catheter.;Is performed by an attendant (e.g. family member or personal aid);Is performed by the individual with spinal cord lesion himself/herself;Implies that there is no voluntary triggering of the voiding, but the individual with spinal cord lesion just let the urine run by itself when the reflex detrusor contraction occur by itself.;Non-continent urinary diversion/ostomy;Voluntary initiation of micturition without reflex stimulation or compression of the bladder. This does not presume entirely normal function (Levi and Ertzgaard 1998).;Other method, specify;Sacral anterior root stimulation;Includes abdominal straining, Valsalva’s manoeuvre.;Suprapubic;indicates, that the urine is drained through a catheter via the abdominal wall.;Indicates, that the urine is drained through a catheter placed in the urethra.;Unknown;Indicates that the bladder reflex is triggered by the spinal cord lesioned individual him/herself or by the attendant.;

Alphanumeric

For each method of bladder emptying, indicate whether this is a main or a supplementary method. Two main and more supplementary methods may be indicated (adopted from Levi and Ertzgaard 1998).